FDA.reportPublic FDA data

ASI Evolution RPR Titration Diluent

Primary DI
00816057021710
Brand
ASI Evolution RPR Titration Diluent
Company
ARLINGTON SCIENTIFIC, INC.
Model
NC-5300-905A
Catalog number
NC-5300-905A
Device description
RPR Sample Diluent used on the ASI Evolution Analyzer for performing sample titrations. 25 ml
Published
2023-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GMQAntigens, Nontreponemal, All

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMQAntigens, Nontreponemal, AllMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816057021710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816057021710008160570217108160570217100816057021710

GMDN Terms#

Term, Definition table
TermDefinition
Treponema pallidum reagin antibody IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
785966607
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816057021666ASI EvolutionNC-2800-000NC-2800-0002023-12-19
00816057021673ASI RPR Test for Syphilis for Use on the ASI EvolutionNC-900480ABBNC-900480ABB2023-12-19
00816057021680ASI RPR Test for Syphilis for Use on the ASI EvolutionNC-9004800ABBNC-9004800ABB2023-12-19
00816057021697ASI RPR Automated Control Set NC-905002.5ANC-905002.5A2023-12-19
00816057021703ASI RPR Automated Control Set NC-905005ANC905005A2023-12-19
00816057021796ASI RPR Card Test for SyphilisNC-900100EXNC-900100EX2023-12-19
00816057021802ASI RPR Card Test for SyphilisNC-900500EXNC-900500EX2023-12-19
00816057021826ASI Color Staph Latex TestNC-285-050NC-285-0502023-12-19
00816057021833ASI Color Staph Latex TestNC-285-050NC-285-0502023-12-19
00816057021840ASI Color Staph Latex TestNC-285-300NC-285-3002023-12-19
00816057020409ASI Rubella TestNC-600030NC-6000302016-07-08
00816057020416ASI Rubella Test NC-600030ENC-600030E2016-07-08
00816057020423ASI Rubella TestNC-600100NC-6001002016-07-08
00816057020430ASI Rubella TestNC-600100ENC-600100E2016-07-08
00816057020447ASI Rubella TestNC-600500NC-6005002016-07-08
00816057020454ASI Rubella TestNC-600500ENC-600500E2016-07-08
00816057020041ASiManager-ATNC-2400-0BTNC-2400-0BT2016-07-08
00816057020058ASI Infinity AnalyzerNC-2700-000NC-2700-0002016-07-08
00816057021628ASI CRP Control SetNC-505001NC-5050012016-07-08
00816057020645ASI EB VCA IgG EIA TestNC-880096-AGNC-880096-AG2016-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850021758233RPR Carbon AntigenKSL Biomedical, Inc.GMQ2026-04-13
B350GSD011600DIL0GSD RPR DiluentGold Standard Diagnostics CorporationGMQ2025-10-16
B350GSD0116005C0Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5CGold Standard Diagnostics CorporationGMQ2024-12-06
B350GSD051600MW0Microtiterplates (5)Gold Standard Diagnostics CorporationGMQ2024-10-22
00816057021666ASI EvolutionARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021673ASI RPR Test for Syphilis for Use on the ASI EvolutionARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021680ASI RPR Test for Syphilis for Use on the ASI EvolutionARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021697ASI RPR Automated Control Set ARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
00816057021703ASI RPR Automated Control Set ARLINGTON SCIENTIFIC, INC.GMQ2023-12-19
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B350GSD051600PC0RPR Reactive ControlGold Standard Diagnostics CorporationGMQ2023-09-13
B350GSD051600W0GSD RPR Microtiterplate - 5 pack sleeveGold Standard Diagnostics CorporationGMQ2022-11-25
B350GSD1600WCASE0MicrotiterplatesGold Standard Diagnostics CorporationGMQ2022-10-14
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10673486000689TECO DIAGNOSTICSTECO DIAGNOSTICSGMQ2021-08-11
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03610522004980BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2018-02-05
03610522015597BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2018-02-05
03610520138267BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2017-07-25
03610520992692BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2017-07-25
03610520653012BioPlex 2200BIO-RAD LABORATORIES, INC.GMQ2017-07-25
10722355001767Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001774Detector RPRImmunostics Company, IncGMQ2016-12-03
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10722355001798Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001804Detector RPRImmunostics Company, IncGMQ2016-12-03
10722355001811Detector RPRImmunostics Company, IncGMQ2016-12-03
B350004000AIX1000 AnalyzerGold Standard Diagnostics CorporationGMQ2016-11-29